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Article 57/xEVMPD Database.
Seamless support for all your essential updates.

What is the Article 57/xEVMPD Database?

The Article 57/xEVMPD (Extended EudraVigilance Medicinal Product Dictionary) database, fulfills the requirements of the European Medicines Agency (EMA) and European National Authorities regarding 57(2) of Regulation (EC) No. 726/2004, which have been obligatory since 2012.

Marketing Authorization Applicants (MAAs), Marketing Authorization Holders (MAHs), and sponsors of clinical trials must provide essential information to the Article 57 database which is systematically collected, reported, coded, and evaluated to ensure the standardisation and structured management of medicinal product data.

xEVMPD’s primary objective is to construct a comprehensive dictionary encompassing all medicines authorized for use throughout the European Union (EU) and the European Economic Area (EEA).

It covers both centrally authorized and nationally authorized products and plays a pivotal role in evaluating product development and authorized adverse drug reactions.

Click for information from the EMA on the Article 57 Database.

The EMA publishes public data from the Article 57 database on all medicines authorised in the European Economic Area (EEA) which includes:

  • Product name (product short name: brand name or the concatenation of the generic name and the company name).
  • Active substance.
  • Route of administration.
  • Country of authorisation.
  • Name of the MAH.
  • Country location of the pharmacovigilance system master file (PSMF).
  • The MAH’s contact email address and telephone number for pharmacovigilance enquiries.

 

The EMA is transitioning the Article 57 database to align with ISO IDMP standards under the phased implementation of SPOR (Substances, Products Organization, Referential), representing a significant step in creating a consistent master data format that will advance pharmacovigilance and regulatory activities.

Why use Aegisana’s Article 57/xEVMPD services?

Organised & efficient.

Our team of experts can effectively oversee and execute all updates related to your product, organizational, and safety information within the Article 57/xEVMPD database.

These updates can seamlessly originate from either our dedicated database or your existing system, ensuring a hassle-free process.

We manage the details.

You can be confident that your data will be up-to-date and accurate, allowing you to focus on your core business operations while we manage the essential details of your regulatory obligations.

Our commitment to excellence in data management ensures that you remain fully compliant

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Belén SegarraRegulatory Affairs Head / Technical Director, Qualix Pharma.
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Alfonso Lomas Pharmacovigilance Activity Coordinator, Mana Pharma.
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José Manuel de la Torre GarcíaQualified Person & Regulatory Affairs Manager, Tora Laboratories.
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Belén SegarraRegulatory Affairs Head / Technical Director, Qualix Pharma.
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Alfonso Lomas Pharmacovigilance Activity Coordinator, Mana Pharma.
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Belén SegarraRegulatory Affairs Head / Technical Director, Qualix Pharma.
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Almudena Pradera DVM PhDChief Scientific Officer, EquiCord.
"A team very involved and responsible in every task developed and service provided. Excellent communication with quick advice and response."
Belén SegarraRegulatory Affairs Head / Technical Director, Qualix Pharma.
"The Aegisana team are experts in everything related to pharmacovigilance, giving us confidence and peace of mind. We work with them as a partner as if they were an internal company department."
Marta ManzanaresRegulatory Affairs, Quality Assurance & Pharmacovigilance Manager, Adamed.

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